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Clinical Research Associate I (Entry Level)

Employer
Labcorp
Location
Miami-Dade County, FL
Closing date
Jan 16, 2022

View more

Sector
Pharmaceutical, Clinical Research Associate
Organization Type
Corporate
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Job Overview:

Seeking Entry Level CRAs for our Oncology Monitoring Excellence Academy across the US!! Can be located in any major hub!

Previous CRC, Site Management, Remote Monitoring, or other applicable experience required.

Are you ready to redefine what's possible, and discover your extraordinary potential at Labcorp? A career here provides the unique chance to create a lasting impact and difference in our patient's lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy & collaborative work place, along with access to comprehensive benefits. Your work will be meaningful, the patient outcomes are real, and the results are lasting. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning.

Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move.

Essential Job Duties:
  • Responsible for all aspects of study site monitoring with or without direct supervision (as per the training status of the CRAI-OMEA). This includes remote and/or onsite conduct of pre-study visits, site initiation visits, routine monitoring visits and close-out visits of clinical sites. Conduct site management activities, maintain study files, liaise with vendors; perform other duties, as assigned.
  • Responsible for aspects of registry management as prescribed in the project plans
  • General On-Site Monitoring Responsibilities:
    • Assist Clinical Research Associate I, II and Sr. CRAs with on-site tasks as required and according to training goals (e.g. review of Case Report Forms, Site Regulatory Files and conduct of drug accountability).
    • Initiate, monitor and close out clinical investigative sites, with or without direct supervision from Clinical Research Associate I, II and Sr. Clinical Research Associates, Clinical Team Leads, Project Managers or Project Directors, as assigned based on training status and adequate skillset acquisition. Until Evaluation Sign-Off visit successfully completed for the CRA I - MEA, should be accompanied by an experienced co-monitor (as per training status and agreement from Line Management).
    • Perform visits as required by the monitoring plan to include those indicated in the chart below.
Onsite with Supervision

PSV

X

SIV

X

RMV with SDV/SDR

X

COV

X

Other (motivational, observational and training visits )

X

Onsite without Supervision

PSV

X

SIV

X

RMV

X

COV

X

Other (motivational, observational and training visits )

X

Remote

PSV

X

SIV

X

RMV

X

RMV with remote SDV/SDR

X

COV

X

Other (motivational, observational and training visits )

X
    • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
    • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
    • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
    • Monitor data for missing or implausible data
  • Ensure the resources of the Sponsor and Labcorp are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Labcorp travel policy
  • Travel, including air travel, may be required as per essential job functions.
  • Prepare accurate and timely trip reports
  • Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Labcorp or client data management systems, as assigned by management
  • Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management
  • Provide coverage for clinical contact telephone lines, as required
  • Update, track and maintain study-specific trial management tools/systems
  • Generate and track drug shipments and supplies, as needed
  • Track and follow-up on serious adverse events as assigned
  • Implement study-specific communication plan as assigned
  • Attend face-to-face meetings or remote meetings/teleconferences as needed (Investigators' meetings, project team meetings, Sponsor meetings, Kick-off meetings etc.) and present certain topics, as assigned.
  • Perform other duties as assigned by the monitoring plan to include those indicated in the chart below.
Other job duties

Essential doc collection

X

Essential doc review

X

Contact for study teams

X

Manage subject screening/enrollment

X

In-house site management

X

Review study data (eCRF)

X

Submission/Renewal to IRB-IEC (as needed per country)

Conduct Site training

X

Regular telephone contact with Sites

X

Documentation of site contacts

X

Assist with preparation of Site Visits

X

Liaise with sponsor/medical monitor

X

Support site payment/budget activities

X

Track and follow up on SAEs

X

Management of study supplies & Investigational Product

X

Mentoring of junior staff

Education/Qualifications:

Minimum Required:
  • External Candidates
  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
AND
  • A minimum of 2 years of experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, )
  • Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirements
  • Basic understanding of the clinical trial process
  • Valid Driver's License
Preferred:
  • Working knowledge of Labcorp SOPs for site monitoring
Experience:

Minimum Required:
  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
AND
  • a minimum of 2 years of industry experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)
  • Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP
  • Ability to work within a project team
  • Good planning, organization and problem solving abilities
  • Good communication skills, oral and written
  • Good computer skills
  • Works efficiently and effectively in a matrix environment
  • Fluent in local office language and in English, both written and verbal
Preferred:
  • One (1) or more additional years of experience in a related field (i.e., medical, clinical, pharmaceutical laboratory, research, data analysis, data management or technical writing) is preferred.
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